Taramasso Lucia, Maggiolo Franco, Valenti Daniela, Blanchi Sabrina, Centorrino Federica, Comi Laura, Di Biagio Antonio
Infectious Disease Clinic, IRCCS Policlinico San Martino Hospital, Genoa, Italy.
Infectious Diseases' Specialist Freelance, Fabro, Italy.
J Acquir Immune Defic Syndr. 2025 Apr 15;98(5):484-490. doi: 10.1097/QAI.0000000000003594.
Few data are available on the forgiveness of 2-drug (2DR) or low-barrier 3-drug antiretroviral regimens. The aim of this study is to evaluate the real-life forgiveness of lamivudine/dolutegravir (3TC/DTG) and emtricitabine/tenofovir alafenamide/rilpivirine (FTC/TAF/RPV).
A 2-center retrospective observational study enrolled all people with HIV treated with 3TC/DTG or FTC/TAF/RPV. Adherence was measured as the proportion of days covered (PDC) by drug supply. Binary logistic regression was used to test the impact of baseline variables and adherence on the achievement of virological suppression.
In total, 1258 adult people with HIV were enrolled, 368 in 3TC/DTG and 890 in FTC/TAF/RPV. Most were men (71%), with a median age of 51 years (IQR 43-58 years) and a median CD4 nadir of 305 cells/mcL (IQR 132-485). Median cohort follow-up was 4558 persons/year. Median adherence, as calculated from PDC, was of 0.98 (IQR 0.93-1). Regardless of the treatment group, a PDC of 0.8 was sufficient to achieve HIV-RNA levels below 200 copies/mL in almost all study participants. With the same level of adherence, >90% of study participants achieved HIV-RNA below 50 copies/mL. PDC ( P < 0.0001), Italian origin ( P < 0.0001), and male sex ( P = 0.038) were significantly correlated with achieving <200 copies/mL.
In this study, we found a similar and high level of forgiveness with the INSTI-based 2-drug regimen 3TC/DTG and the NNRTI-based 3-drug regimen FTC/TAF/RPV.
关于双药（2DR）或低门槛三药抗逆转录病毒治疗方案的宽容度，现有数据较少。本研究的目的是评估拉米夫定/多替拉韦（3TC/DTG）和恩曲他滨/替诺福韦艾拉酚胺/利匹韦林（FTC/TAF/RPV）在实际应用中的宽容度。
一项2中心回顾性观察性研究纳入了所有接受3TC/DTG或FTC/TAF/RPV治疗的HIV感染者。依从性通过药物供应覆盖天数比例（PDC）来衡量。采用二元逻辑回归来检验基线变量和依从性对病毒学抑制实现情况的影响。
总共纳入了1258名成年HIV感染者，其中368人接受3TC/DTG治疗，890人接受FTC/TAF/RPV治疗。大多数为男性（71%），中位年龄为51岁（四分位间距43 - 58岁），CD4细胞计数最低点中位数为305个/微升（四分位间距132 - 485）。队列中位随访时间为4558人年。根据PDC计算的中位依从性为0.98（四分位间距0.93 - 1）。无论治疗组如何，几乎所有研究参与者的PDC达到0.8就足以使HIV - RNA水平低于200拷贝/毫升。在相同依从性水平下，超过90%的研究参与者HIV - RNA低于50拷贝/毫升。PDC（P < 0.0001）、意大利裔（P < 0.0001）和男性（P = 0.038）与HIV - RNA低于200拷贝/毫升显著相关。
在本研究中，我们发现基于整合酶链转移抑制剂（INSTI）的双药方案3TC/DTG和基于非核苷类逆转录酶抑制剂（NNRTI）的三药方案FTC/TAF/RPV具有相似且较高的宽容度。
